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NCT Number: NCT07312149

Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy

Atrial Fibrillation (AF) is the most common cardiac arrhythmia worldwide, affecting approximately 2.8% of the population, with prevalence increasing with age. AF is associated with significant morbidity and mortality, accounting for about 25% of ischemic strokes, 10% of cryptogenic strokes, and a 10-40% annual increase in hospital admissions due to heart failure or anticoagulant-related events.

About 10% of patients undergoing cardiac surgery have preoperative AF. In 1986, Dr. Cox introduced the MAZE procedure, a surgical technique to isolate AF triggers. Initially involving atrial incisions, it evolved to use radiofrequency lines, significantly reducing morbidity and mortality. The MAZE procedure is now strongly recommended (Class Ia evidence) for concomitant cardiac surgery. However, nearly 85% of eligible patients-especially those undergoing closed-chest cardiac surgery-do not receive this treatment due to technical challenges and limited reproducibility of the Cox-Maze IV technique.

Pulmonary Vein Isolation (PVI) with posterior wall isolation (PWI-Box) has emerged as an effective alternative, offering similar outcomes to Cox-Maze IV with fewer adverse effects. Innovative devices like the GeminiS (Medtronic) enable minimally invasive, thoracoscopic PVI-PWI-Box procedures without opening the heart, even off-pump. This approach could expand the use of AF ablation during combined sternotomy surgeries, aligning with clinical guidelines.

Primary Objective: Assess the efficacy of PWI-Box using GeminiS combined with other cardiac surgeries via sternotomy.

Primary Endpoint: Recurrence rate of paroxysmal or persistent AF (per ESC definition) at 1 year postoperatively, confirmed by 24-hour Holter monitoring.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing cardiac surgery via sternotomy
  • Concomitant use of the PWI box with GeminiS during surgery
  • Adult patients
  • Patients with the following characteristics: Preoperative paroxysmal/persistent/permanent AF; Duration of less than 5 years; And left atrium volume <60 ml/m2
  • Informed patient who did not object to the collection of their data for the study

Exclusion criteria

  • Unplanned surgery (emergency)
  • History of cardiac surgery (reoperation)
  • Pregnant or breastfeeding women
  • Adults under guardianship, curatorship or judicial protection
  • Patients with a life expectancy of less than three years
  • Patients currently taking medication or using an experimental device that clinically interferes with the study's evaluation criteria and results.
  • Inability to comply with the monitoring schedule.
  • Contraindication to long-term anticoagulants

Treatment and study plan

Collection of study data from patient records

Other

Collection of study data from patient records in the EPICARD national database at the time of surgery, 1 month post-surgery, 12 months post-surgery, 24 months post-surgery and 36 months post-surgery.

Primary outcomes

  1. Evaluate the efficacy of the PWI box, using GeminiS in combination with other cardiac surgery procedures via sternotomy, at 1 year post-operatively using 24-hour Holter monitoring.

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 2 years postoperatively.

    Time frame: 24 months

  2. Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 3 years postoperatively.

    Time frame: 36 months

  3. Evaluation of the rate of secondary endocardial ablation of AF.

    Time frame: 12 months

  4. Evaluation of clinicals predictive factors for recurrence of AF after MAZE.

    Time frame: 36 months

  5. Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery.

    Time frame: 36 months

  6. Assessment of complication rates associated with the technique used during cardiac surgery.

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsor

CONTACT

[email protected]

02 53 48 28 35 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

BoxTer : Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy

Acronym: BoxTer

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Dec 31, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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